Clareon™ CC60WF (UDI 00380652396837)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon™ Aspheric UV Absorbing IOL - STERILE UV-Absorbing Hydrophobic Acrylic Foldable Aspheric Posterior Chamber Intraocular Lens · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon Clareon CC60WF is a foldable plastic lens implanted in the eye during cataract surgery. The 62 reports mostly describe lens handling problems before or during implantation: scratched or cracked material, pieces breaking off, lenses drying out or jamming in the injector, and marks or extra bits on the lens surface. Seven injuries were reported and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 62
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00380652396837), received between Aug 22, 2022 and Aug 25, 2026 — classified as 7 injuries, 55 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (17 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Scratched Material17
- Break11
- Defective Device9
- Adverse Event Without Identified Device or Use Problem6
- Material Split, Cut or Torn4
- Product Quality Problem4
- Dent in Material3
- Material Twisted/Bent3
Patient problems
- Insufficient Information35
- No Clinical Signs, Symptoms or Conditions22
- Visual Impairment3
- Blurred Vision1
- Corneal Edema1
- Diplopia/Double Vision1
- Dry Eye(s)1
- Eye Irritation1
Recent adverse event reports
The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2026Failure to Deliver
A non-healthcare professional reported that during an intraocular lens (IOL) implant procedure, reported IOL Jammed into injector or injector problem.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50433179 ↗MalfunctionJun 9, 2026Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DRIED OUT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25446100 ↗MalfunctionJun 9, 2026Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DRIED OUT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25446099 ↗MalfunctionJun 5, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A MARK WAS OBSERVED ON THE BACK OF THE LENS AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25413916 ↗MalfunctionMay 15, 2026Product Quality Problem
A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS FINE AND EACH HAPTIC HAD A NORMAL BULB. THE SURGEON THEN NOTICED AN EXTRA BULB ON THE EDGE OF THE OPTIC. THE SURGEON WAS ABLE TO EASILY REMOVE THE EXTRA PIECE, AND THERE WERE NO ISSUES. THE ORIGINAL IOL REMAINED IN THE EYE, AND ONLY THE EXTRA PIECE WAS REMOVED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, IN THE SURGEON'S OPINION, A SMALL REMNANT OF THE END OF A HAPTIC WAS PRESENT ON THE OPTIC. BOTH HAPTICS OF THE IMPLANTED LENS WAS INTACT, AND THE SURGEON CONSIDERED THAT THE REMNANT ORIGINATED FROM ANOTHER LENS, WHICH CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25185311 ↗MalfunctionApr 23, 2026Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS FOUND TO BE DEFECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24971160 ↗MalfunctionApr 17, 2026Break
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED THAT HAPTIC WAS CRACKED BUT THE TECHNICIAN REALIZED IT WHEN TRIED TO LOAD IT THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24912708 ↗MalfunctionMar 11, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE CUSTOMER WAS UNSURE OF THE DEFECT REPORTED BY SURGEON AND IS REACHING OUT FOR MORE INFORMATION. THERE WAS A PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, IN THE SURGEON OPINION EITHER LENS WAS ALREADY SCRATCHED OR THE INSERTER WAS BENT AND SCRATCHED THE LENS, BUT IT WAS NOTED IN THE CARTRIDGE. SO, THE LENS WAS REMOVED TO CHECK AND SCRATCH WAS SEEN SO IT WAS NOT REFOLDED. A NEW LENS WAS USED TO COMPLETE THE PROCEDURE ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 24574790 ↗MalfunctionFeb 12, 2026Break
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT UPON OPENING THE PACKAGE AND GRABBING THE LENS TO LOAD IT, IT WAS NOTICED THAT A HAPTIC WAS MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24322084 ↗MalfunctionFeb 10, 2026Break
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS TORN OR BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24304178 ↗MalfunctionJan 9, 2026Inaccurate Delivery
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS FLIPPED UPSIDE DOWN. THERE WAS NO PATIENT CONTACT. A NEW LENS WAS OPENED AND COMPLETED THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24021200 ↗MalfunctionJan 6, 2026Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED A SCRATCH OR MARK ON OPTIC / BLEMISH/INDENTATION/SCUFF MARK/SCORE MARK ON OPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23975325 ↗MalfunctionDec 25, 2025Product Quality Problem; Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE LENS WAS DEFECTIVE AND THEY DID NOT IMPLANT THE LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23891625 ↗MalfunctionDec 23, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE SURGEON NOTICED SCRATCH ON LENS. THE LENS WAS IMPLANTED AND EXPLANTED DURING INITIAL PROCEDURE AND REPLACED WITH COMPANY LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23876715 ↗MalfunctionDec 23, 2025Material Twisted/Bent; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A BENT HAPTIC WAS OBSERVED. THERE WAS NO PATIENT CONTACT OR HARM, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME MODEL LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23876227 ↗InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO FURTHER IMPACT TO THE PATIENT.
Patient problems: Visual Impairment
MAUDE report 23854332 ↗MalfunctionDec 9, 2025Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC BROKE OFF WHEN THE LENS WAS INJECTED INTO THE PATIENT EYE. THE LENS WAS EXPLANTED AND THE STAND-BY LENS WAS IMPLANTED WITHOUT ANY ISSUE IN THE SAME PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED, THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23756625 ↗MalfunctionDec 4, 2025Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) HAD JAGGED NOTCHES IN THE CENTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED LENS HAD NOTCHES ON IT. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED SAME DAY WITH UNSPECIFIED LENS WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23716495 ↗InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD NOT EXPERIENCED GOOD VISION SINCE THE SURGERY. THE PATIENT DESCRIBED HER VISION AS HAVING SHIMMERS, WITH SENSATIONS OF JIGGLING, VIBRATING, AND FLUTTERING SIMILAR TO LOOKING UNDERWATER. IT WAS NOT THE EYEBALL ITSELF, BUT WHEN HER HEAD WAS HELD STRAIGHT, HER ENTIRE VISUAL FIELD APPEARED TO BE JIGGLING.
Patient problems: Visual Impairment
MAUDE report 23657943 ↗InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD NOT EXPERIENCED GOOD VISION SINCE THE SURGERY. THE PATIENT DESCRIBED HER VISION AS HAVING SHIMMERS, WITH SENSATIONS OF JIGGLING, VIBRATING, AND FLUTTERING SIMILAR TO LOOKING UNDERWATER. IT WAS NOT THE EYEBALL ITSELF, BUT WHEN HER HEAD WAS HELD STRAIGHT, HER ENTIRE VISUAL FIELD APPEARED TO BE JIGGLING.
Patient problems: Visual Impairment
MAUDE report 23656604 ↗MalfunctionOct 28, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED SCRATCH ON LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO PATIENT HARM. IN THE SURGEON¿S OPINION, THE SCRATCH ON LENS WAS POSSIBLY FROM COMPANY PLUNGER PASSING OVER CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23404561 ↗MalfunctionOct 17, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS FAULTY (NOT HAPTIC) / LENS COULD NOT BE USED. THE SURGEON SAID THERE WAS A NOTCH OUT OF THE BACK SIDE OF THE LENS. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE LENS WAS REMOVED FROM THE PATIENT EYE AND REPLACED WITH A LENS OF SAME MODEL AND DIOPTER IN THE SAME PROCEDURE. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23331416 ↗MalfunctionSep 9, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED SCRATCHED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23003437 ↗MalfunctionAug 11, 2025Break; Break
ADDITIONAL INFORMATION WAS RECEIVED AS THERE WAS NO PATIENT HARM. THE LENS WAS INSERTED AND REMOVED FROM THE PATIENT EYE DURING INITIAL PROCEDURE. UPON REMOVAL, INTRAOCULAR LENS WAS DIFFICULT TO REMOVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22771086 ↗MalfunctionAug 6, 2025Break; Break
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE TECH PICKED UP THE LENS, HE NOTED THE HAPTIC WAS MISSING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22731093 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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